Phase
Condition
Allergy (Pediatric)
Allergy
Respiratory Syncytial Virus (Rsv) Infection
Treatment
Difflam
Flurbiprofen 8.75 MG
Flurbiprofen Oral Lozenge
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
An onset of any 2 URTI symptoms in past 3-5 days, such as a sore throat, fever,coughing, coughing up phlegm, sneezing, and runny nose;
A current cough or urge-to-cough rated at least 5 in severity and/or ranking coughas subject's most bothersome symptom on Cold Symptoms Questionnaire (CSQ);
A feeling of sickness interfering with their daily life, rated as at least mildly;
A cough consistent with acute cough - i.e., cough onset with URTI and not ongoing,chronic cough;
Written informed consent and a willingness and ability to comply with the studyprotocol.
Exclusion
Exclusion Criteria:
A pre-existing chronic lung disease (asthma, COPD, chronic bronchitis etc), toexclude these as causes for cough;
The use of inhaled or systemic steroids / broncho-active medication, ACE inhibitors,oral or inhaled antihistamines, opiates, gabapentin, tricyclic antidepressants (current or within the past 3 months), as these will alter airway inflammatoryprofiles and/ or cough sensitivity;
A current cigarette or marijuana smoker/vaper, recreational drug user, or have givenup smoking/vaping within the last 12 months, or a former smoker with greater than 20pack-years, alter airway inflammatory profiles and/ or cough sensitivity;
Pre-existing chronic cough (cough persisting for more than 8 weeks): unexplainedchronic cough (UCC) or refractory chronic cough (RCC) associated with or without apre-existing condition (GERD, rhinitis, etc), as we are studying acute cough;
Prior experience of an allergic or bad reaction to capsaicin or chilli (which israre);
Prior experience an allergic or bad reaction to a non-steroidal anti-inflammatorydrug (NSAID) such as ibuprofen;
Ongoing or history of stomach ulcer, impaired kidney or liver function, or heartfailure;
Pregnancy, lactation or actively trying to become pregnant;
Currently taking other products with flurbiprofen, aspirin or otheranti-inflammatory medicines;
Evidence of COVID-19 positivity, either during the COVID Rapid Antigen Testadministered on the day of assessment or have informed us that they have becomepositive in the 24-48 hours after the testing session (i.e., participants who werelikely positive during assessment but under the detection threshold);
Participants who cannot provide informed voluntary consent.
Study Design
Study Description
Connect with a study center
University of Melbourne
Carlton, Victoria 3010
AustraliaSite Not Available
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